Lilly's mazdutide completes Phase 2 alcohol use disorder trial, data pending
The 308-patient placebo-controlled study wrapped up with no efficacy data yet posted, leaving the GLP-1 drug's bid for a new indication unresolved.
Executive Summary
- Eli Lilly and Company's Phase 2 trial testing mazdutide against placebo in alcohol use disorder has finished, with no efficacy or safety result yet made public.
- The trial tests whether a GLP-1 receptor agonist, a mechanism validated for weight loss and diabetes, can also change drinking behavior, a question with no approved GLP-1 option to answer it yet.
- Mazdutide is the sole GLP-1 receptor agonist tested against alcohol use disorder in a completed industry trial, but Lilly itself is already running a separate, larger program in the same indication with a different candidate.
- The study closed on a routine enrollment and timeline path, with its primary completion date pulled forward rather than delayed, which supports rather than undercuts confidence in the pending data.
The trial
The study, registered as NCT06817356, randomized patients with a current alcohol use disorder diagnosis under DSM-5 criteria to receive subcutaneous mazdutide or placebo across two arms. Its primary endpoint measures behaviors associated with alcohol use disorder using the Timeline Followback method, a self-report measure of drinking days and quantity, assessed from baseline through week 28. The trial excluded patients with recent unstable psychiatric illness or recent use of approved alcohol use disorder medications such as naltrexone or acamprosate, narrowing the population to a relatively uncomplicated addiction cohort. NCT06817356A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use DisorderNCT06817356
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
Enrollment and timing
Lilly enrolled 308 patients, slightly above its original 300-patient target, and the registry marked enrollment as actual rather than anticipated as of late June 2026. The primary completion date moved from an anticipated August 2026 to an actual March 19, 2026, a pull-forward rather than a slip. The trial's status advanced from recruiting to active-not-recruiting in March 2026 and to completed in July 2026, a sequence consistent with a study that finished enrollment and follow-up on its own schedule. NCT06817356A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use DisorderNCT06817356
What is not yet known
No results have posted on the trial's public registry record, and the primary result summary, safety profile, and whether the primary endpoint was met remain unreported as of this writing. The trial is not designed as a registrational study, so its function is to generate a signal on whether mazdutide reduces drinking behavior, which would inform Lilly's decision on whether to pursue a larger, indication-specific program. NCT06817356A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use DisorderNCT06817356
Competitive position
No other industry trial pairs a GLP-1 receptor agonist with alcohol use disorder as its indication, based on the trials on record for this target and disease combination. Lilly itself, however, is separately testing brenipatide, a different GLP-1 receptor agonist, in a Phase 3 alcohol use disorder trial, alongside three related studies. That means the closest comparator to mazdutide's result is not a rival sponsor but Lilly's own more advanced internal program targeting the same disease and mechanism class. Beyond alcohol use disorder, the GLP-1 receptor agonist class is heavily populated: Novo Nordisk's semaglutide, Boehringer Ingelheim's survodutide, and Amgen's maridebart cafraglutide are all advancing Phase 3 or Phase 4 programs in obesity, NASH, and related metabolic disease, underscoring how mature the mechanism is outside addiction medicine even as its use in alcohol use disorder remains untested at scale.
No approved options
No GLP-1 receptor agonist currently holds FDA approval for alcohol use disorder; the drugs that do carry GLP-1 receptor agonist approvals, including liraglutide, dulaglutide, and tirzepatide, are approved for type 2 diabetes or obesity, not for this indication. That leaves the current standard of care in alcohol use disorder built on non-GLP-1 mechanisms, and it means mazdutide's result, whenever disclosed, would be read against no established GLP-1 efficacy benchmark in this disease rather than against a validated comparator.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.